JP2021500190A - Easy-to-control transport device - Google Patents

Abstract

It is a transport device of a feeding device that is easy to control, and includes a core tube (7), and a guide head (2) and a fixed head (3) are fixed on the core tube (7), and the guide head (7) is fixed. 2) is fixed to the far end of the core tube (7), and the near end side of the core tube (7) crosses the fixed head (3) and is between the guide head (2) and the fixed head (3). Is the mounting position of the feeding device. An external sheath tube (5) capable of sliding in the axial direction is attached around the attachment position of the feeding device. The floating positioning unit (1) is further included, the near end of the floating positioning unit (1) is the start end (13) connected near the fixed head (3), and the far end is the transport device of the feeding device. The ends (11, 101) that float to and from the outer sheath tube (5). An easy-to-control delivery device transport device pulls on the end of the valvular stent (8) when the stent is released, preventing the valvular stent (8) from completely falling during the release process and releasing the stent. The frictional force between the transport system and the valve membrane can be reduced when recovering.

Description

The present invention belongs to the field of medical devices and specifically relates to a transport device that delivers an artificial valvular heart to the heart.

Diseases related to valvular heart disease are a type of heart disease that is often seen in Japan, and it is damage to the valvular membrane caused by rheumatic fever. In recent years, with the development of aging, valve membrane damage due to degeneration of the valve membrane (including (calcification) and degeneration of mucus) and metabolic disorders has increased. Congenital valvular disease is also a common type of heart disease. For patients with severe valvular heart disease, such as severe valvular insufficiency, elderly patients who cannot replace the valvular membrane by surgery, terminal masses, valvular insufficiency, etc., it is necessary to invent a delivery treatment method with less damage. is there. Rechargeable valvular heart disease has evolved from valvular heart replacement surgery. In recent years, subcutaneous valve membrane delivery surgery has been invented and has been successful in application and clinical practice since 2000. In the research staircase, which has evolved from experimental research to small-scale clinical practice, it is possible to solve technical "problems" by valvular transfer and quickly realize large-scale clinical practice. Can attract attention in.

In the prior art, an artificial valvular stent is compressed and then delivered into the body by a transport device. The compressed valvular stent is elastic, and the compressed valvular stent exerts a large force on the compression guide tube. Due to the large force, the valvular stent cannot be released gradually and accurately, and a large friction may be formed between the valvular stent and the inner wall of the blood vessel.

An artificial valvular stent is published in a Chinese patent with publication number CN1019573725. The heart valve stent is composed of a main artery stent, a valve stent, an outflow stent and a connecting ear. When the valvular heart is compressed and delivered into the transport device, the connecting ear is coupled to the stent-fixing module of the transport device. When releasing the valvular heart, the valvular heart can be released gradually by the connection of the connecting ear and the binding of the external sheath tube. However, since the binding force applied to the connecting selvage portion of the valvular stent in the prior art is small, the valvular stent is suddenly and completely released when the connecting ear portion is ejected from the stent fixing module of the transport device in the later stage of releasing the valvular stent. There is a risk of being Therefore, even if a problem such as a position error occurs, the valvular stent cannot be recovered quickly, and the valvular stent must be replaced by a surgical method (surgical method).

In order to prevent the above problems from occurring when the valvular stent is delivered into the body and released, a transmission device and method for controlling the release of tubular prosthesis are proposed in US Pat. No. US5683451. Specifically, by installing a rail in the transmission device, the frictional force applied to the transport guide tube by elastic expansion when transporting and releasing the prosthesis is reduced. According to the invention, the friction between the prosthesis and the transport guide pipe can be reduced. However, the invention cannot solve the problem that the valvular stent is suddenly completely released due to its high elasticity when the valvular stent is released, and the position of the released valvular stent is adjusted or moved again. Since it is not possible, the demand for controlling the valvular stent during surgery is extremely high and there is a risk of failure.

The present invention provides a transport device that controls the release of a feed device. As a result, in the process of releasing the feeding device, when the feeding device is released by fixing the end portion of the feeding device, the feeding device becomes uncontrollable due to the great elasticity and separates from the fixed head. This can be prevented and the delivery device can be repositioned and recovered during the release process.

An easy-to-control transport device for feeding devices, including a core tube, with a guide head and a fixed head fixed on the core tube, and the guide head fixed to the far end of the core tube. The near end side goes beyond the fixed head, and the feeding device mounting position is between the guide head and the fixed head, and an external sheath tube that can slide in the axial direction around the feeding device mounting position. Is attached,
A floating positioning portion is further included, the near end of the floating positioning portion is a start end provided so as to be immovable with respect to a fixed head or a core tube, and the far end is a transport device of a feeding device and an external sheath tube. Is the end that floats between
A positioning portion to be connected to the connecting ear portion of the feeding device is formed on the outer wall of the fixed head, and when the feeding device is in the mounted state, the floating positioning portion is connected by being bound by the external sheath tube. Ensure a bond between the ears and the positioning section.

In the present invention, the floating positioning portion is located between the external sheath tube and the feeding device, so that the external sheath tube pulls the feeding device in the radial direction and prevents the feeding device from falling in an uncontrolled state. be able to. Further, the floating positioning portion can reduce the contact area between the external sheath tube and the feeding device to some extent, and can reduce the relative frictional force at the time of contact. The force operated by the doctor when advancing or retracting the external sheath tube can be reduced and the release and recovery of the delivery device can be precisely controlled.

It can be understood that the mounting position of the feeding device is a position in the space where the feeding device to be mounted is located. An important part of the feeding device is located between the far end of the fixed head and the near end of the guide head, but for easy positioning, the local part of the feeding device is located between the fixed head and the guide head. It can also be mounted on the outer wall. The position in space where the mounted feeding device is located can be axially located and between the far end of the fixed head and the near end of the guide head.

The floating positioning section can swing freely relative to the feeding device or core tube when not bound by the external sheath tube, or can maintain its relative position and orientation due to its own material strength. "Floating" means that when one end is fixed and the other end is not bound by the outside, it can swing at least in the diametrical direction, and it also allows a shift in the circumferential direction due to its own material strength.

The mounting state of the feeding device includes a pre-release state in which the external sheath tube completely wraps the feeding device and a semi-release state in which a part of the feeding device is exposed. In the mounted state, the floating positioning portion is the external sheath. By receiving the binding of the tube, the connection between the connecting ear part and the positioning part of the feeding device is secured, and the connecting ear part is prevented from separating from the fixed head.
When the external sheath tube completely exposes the feeding device, the feeding device is in the releasing state, and in the releasing state, the floating positioning portion removes the acting force for maintaining the connection between the connecting selvage portion and the positioning portion. As a result, the connecting ear portion of the feeding device can be separated from the positioning portion.

Only when the floating positioning portion is in the mounted state, the stability of the connection between the connecting ear portion of the feeding device and the positioning portion is ensured.

The coupling connection structure of the feeding device and the positioning portion is a connecting portion of the feeding device, and the connecting ear portion of the feeding device is at least a part of the connecting portion.

The positioning portion includes an open area that allows a change in the radial position of the connecting selvage portion, and in the mounted state, the floating positioning portion may seal the open area and seal all or a part of the open area. it can.

An open area is formed in the radial direction of the positioning portion, and the connecting selvage portion can be separated from the positioning portion by the open area when the feeding device is released. In the worn state, the floating positioning portion seals the open area to prevent detachment of the connecting ear portion. In the opening area of the outer peripheral surface of the fixed head facing the open area, the floating positioning part under the pre-release state causes the floating positioning part to seal all or a part of the open area.

When the feeding device is mounted in the external sheath tube, the floating positioning portion is bound by the external sheath tube, so that the connection between the connecting selvage portion and the positioning portion can be ensured. When the connecting selvage portion is gradually released by retracting the outer sheath tube, the floating positioning portion is also released from the outer sheath tube to the outside. When the connecting selvage is fully released and away from the fixed head, the floating positioning part can swing freely, and the released floating positioning part does not exert radial pressure on the connecting selvage, so that the connecting ear is not applied. Do not limit the position of the part.

When the feeding device is mounted inside the external sheath tube, the floating positioning part acts like a spacer to compensate for the coupling error between the external sheath tube and the connecting ear, and the external sheath tube and the connecting ear. It is possible to fill the gap in the radial direction between the portions. The floating positioning part has a simple structure, and filling the gap does not increase the diametrical size of the transport system. The strength of the connection between the conventional feeding device and the fixed head can be increased, and the performance of the connection can be made more stable. The diametrical pressure exerted by the floating position on the connecting selvage is simultaneously relieved by retracting the outer sheath tube and does not give new interference to the well-released valve membrane.

Preferably, the start end of the floating positioning portion is fixed to at least one of the fixed head or the core tube.

The position of the fixed head on the core tube, or at least the axial position, is fixed. The start end of the floating positioning portion is fixed to at least one of the fixed head or the core tube.

The near end of the floating positioning portion is fixedly connected to at least one of the following portions.
(A) It is fixedly connected on the fixed head.
(B) Fixedly connected on the core tube and located on the near end side of the fixed head.

The near end of the floating positioning portion is connected to the core tube or fixed head, and the far end of the floating positioning portion is provided so as to float with respect to the core tube or fixed head. For example, the fixed position of the start end of the floating positioning part is located near the fixed head or on the tail of the near end of the fixed head (in the direction in which the transport device approaches the user) or on the core tube connected to the tail. .. When the feeding device and the floating positioning portion are housed in the external sheath tube before the operation, the floating positioning portion abuts on the outer circumference of the feeding device along the radial direction. The fact that the floating positioning unit abuts on the outer circumference of the feeding device means that it abuts only on the outer circumference of the feeding device and does not enter the inside of the feeding device. When the feeding device is fed into the body and discharged, the floating positioning portion is bent outward in the radial direction due to the withdrawal of the external sheath tube and the discharge of the feeding device.

When the floating positioning portion is not bound by the external sheath tube, the radial position is changed by changing the local or overall shape, allowing the connecting selvage to separate from the positioning portion along the radial direction. be able to. At least a part of the floating positioning portion has a deformable structure, and an elastic material and / or a hinge structure can be adopted as the deformable structure.

Preferably, the positioning portion is a positioning protrusion, and when the feeding device is in the mounted state, the connecting selvage portion is coupled on the positioning protrusion portion and the floating positioning portion is superimposed on the outside of the connecting selvage portion. Ensures the connection between the connecting selvage and the positioning part.

Preferably, the positioning portion is a positioning groove (tank), and when the feeding device is in the mounted state, the connecting selvage portion is coupled in the predetermined positioning portion, and the floating positioning portion is superimposed on the outside of the connecting selvage portion. By doing so, the connection between the connecting selvage portion and the positioning portion is secured.

In order to control the axial position of the feeding device, a connecting ear portion to be connected to the fixed head is formed at the near end of the feeding device, and the connecting ear portion is T-shaped, L-shaped, annular, or U-shaped. , V-shaped, etc., and the positioning portion can be a positioning groove for accommodating the T-shaped or L-shaped connecting ear portion or a protruding portion coupled to the annular, U-shaped, or V-shaped connecting ear portion. .. The axial position of the feeding device under the mounted state is limited by the positioning unit. The prior art is adopted as the shape of the connecting selvage portion of the present invention, and the shape of the connecting selvage portion is not intended to be improved by the present invention.

The portion inserted into the positioning groove of the floating positioning portion contacts the connecting selvage portion or abuts on the connecting selvage portion in the direction toward the inside in the radial direction.

The positioning portion is a positioning protrusion or a positioning groove, and when in the mounted state, the connecting selvage portion is coupled to the positioning protrusion or inserted into the positioning groove.

In the mounted state, the floating positioning portion directly superimposes on the connecting selvage portion or seals the open area of the positioning portion to secure the connection between the connecting selvage portion and the positioning portion.

Overlapping on the connecting ears means sealing the open area. At that time, the gap in the radial direction is limited, and the floating positioning portion contacts the connecting selvage portion and pushes the connecting selvage portion. When the radial gap between the external sheath tube and the positioning part is large, the floating positioning part cannot directly contact the connecting selvage in the radial direction, and locks the connecting selvage by sealing the open area. Can be made to. When the gap in the radial direction is filled in the floating positioning portion, it is necessary to ensure that the connecting selvage portion is separated from the positioning portion by being thinner than the thickness of the connecting selvage portion. In the mounted state, the outer side of the floating positioning portion in the radial direction abuts on the inner wall of the outer sheath tube, the back side of the floating positioning portion in the radial direction abuts on the connecting ear portion, and the floating positioning portion and the feeding device are connected. At the contact portion of the selvage portion, all of the floating positioning portions are located outside in the radial direction of the feeding device.

In the mounted state, the floating positioning portion is at the same height as the outer wall of the fixed head or higher than the outer wall of the fixed head in the radial direction.

In the mounted state, the floating positioning portion is bound by the external sheath tube to form at least a component force in the diametrical direction, and the component force in the diametrical direction is applied to the connecting ear portion of the feeding device to the outside in the diametrical direction. It prevents the movement and enhances the contacting portion of the feeding device with the fixed head.

The positioning protrusion or the positioning groove is a portion where the positioning portion is connected to the connecting ear portion, has a structure that restricts the axial movement of the connecting ear portion in the wearing state, and is positioned by the feeding device in the releasing state. Axial restrictions on movement relative to the selvage can be removed.

In the mounted state, a part or all of the portion coupled to the positioning groove of the floating positioning portion is inserted into the positioning groove along the radial direction.

For example, when a positioning groove is adopted, the connecting ears under the wearing state are coupled into the positioning groove to determine the axial position, and after the external sheath tube is withdrawn, the connecting ears are moved in the diameter direction of the stent. It can be separated from the positioning groove along.

A protruding structure can also be used when the positioning groove is adopted. That is, the effect of positioning can be improved by forming a protruding structure at the bottom of the positioning groove and making the shape of the protruding structure correspond to the shape of the connecting selvage portion.

The connecting selvage has a U-shaped structure or an annular structure, and one side of the opening of the U-shaped structure or one side of the opening of the annular structure is connected to the feeding device. The positioning portion on the fixed head is a positioning protrusion, and the U-shaped structure or the annular structure is coupled to the positioning protrusion. The U-shaped structure or the annular structure can be positioned in the axial direction by being coupled to the positioning protrusion. An insertion groove is formed on the outer circumference of the positioning protrusion, that is, the outer wall of the fixed head, in order to prevent the connecting selvage portion from protruding excessively outward in the radial direction. By superimposing the connecting ears in the insertion groove, the height in the radial direction thereof and the outer wall of the fixed head can be made the same height.

Preferably, the numbers of the floating positioning portions and the positioning grooves are the same, and the positions in the circumferential direction correspond one-to-one.

The positioning groove can prevent the floating positioning portion from moving when it is retracted or released.

The near end portion of the floating positioning portion in the mounted state is tightly coupled to the positioning groove by being wrapped in an external sheath tube and inserted into the connecting ear portion thereof. When the external sheath tube is withdrawn to release the feeding device, the floating positioning portion applies pressure to the positioning groove, so that the feeding device can be prevented from falling in an uncontrolled state. If an error is formed in the position when the feeding device is released, the released feeding device can be compressed and recovered by advancing the outer sheath tube. At that time, the connecting selvage portion is tightly wrapped in the floating positioning portion and the external sheath tube so that the feeding device can be safely controlled and its position can be repositioned.

Preferably, the end of the floating positioning portion extends at least to a position corresponding to the connecting ear portion. That is, the movement of the connecting selvage in the radial direction is restricted by covering at least a part of the connecting selvage. Further, the end of the floating positioning portion can be further extended toward the far end side so that it can move freely in the axial direction.

Preferably, the floating positioning portion has a single strip type structure, or the floating positioning portion has a fork structure, and the non-fork type structure of the floating positioning portion is fixed to the outside of the fixed head, and the fork structure is far away. The ends extend to the outside of the connecting ears so as to overlap the connecting ears.

The end of the floating positioning portion is opposed to the start end, and the end can be understood as the far end side of the floating positioning portion.

Preferably, the farthest end of the floating positioning portion is aligned with the farthest end of the fixed head, does not protrude from the farthest end of the fixed head, or slightly protrudes from the farthest end of the fixed head.

When the floating positioning portion has the minimum length, the floating positioning portion can cover at least the connecting selvage portion. In order to further improve the effect of contact, the end of the floating positioning portion can be further extended to the far end side of the fixed head or slightly beyond the far end side of the fixed head. For example, its length may be less than or equal to 1 cm.

The end of the floating positioning section can extend to the maximum diameter area of the feeding device. After the feeding device is released, the diameter of each part is different and the end of the floating positioning part can extend to the maximum diameter area of the feeding device.

When the floating positioning part has the maximum length, each part of the floating positioning part is housed in the outer sheath tube, and the end of the floating positioning part and the far end side of the feeding device in the outer sheath tube are aligned. Can be ensured. At that time, the length of the floating positioning part can wrap the entire feeding device, and the floating positioning part acts as a rail to ensure that the outer sheath tube moves forward and backward along the rail and feeds. It is possible to prevent direct contact with the input device.

When the feeding device is in the mounted state, the floating positioning portion receives the restraint of the outer sheath tube to position the connecting ear portion in the positioning groove, and the inner wall of the outer sheath tube and the floating positioning portion come into contact with each other to form a diameter. Provides directional binding. The floating positioning portion prevents the connecting selvage portion from coming off by fixing the connecting selvage portion in the positioning groove.

Preferably, the positioning groove penetrates in the axial direction, and a part or all of the portion coupled with the positioning groove of the floating positioning portion is inserted into the positioning groove.

The floating positioning portion extends toward the far end side by a positioning groove, and the positioning groove penetrates in the axial direction and is open on the outside in the radial direction. That is, since the positioning groove has an opening in the diametrical direction, the floating positioning portion is not collected only on the back side of the opening in the diametrical direction, and a part of the floating locating portion can be located outside the opening in the diametrical direction. .. For example, when the cross section of the floating positioning portion is T-shaped, the bottom of the T-shape is inserted into the positioning groove to limit the movement of the connecting selvage portion, and the size of the top of the T-shape is larger than the opening in the radial direction. The T-shaped top is located outside the diametrical opening. Thereby, the connection between the floating positioning portion and the inner wall of the outer sheath tube can be secured, and the connection between the floating positioning portion and the connecting ear portion can also be secured.

Preferably, the axial penetration area of the positioning groove is completely sealed by the floating positioning portion.

The width of the floating positioning section is equal to or slightly wider than the radial opening of the axial penetration area to prevent detachment of the connecting selvage. Thereby, the opening in the radial direction can be completely sealed. Even if the width of the floating positioning portion is smaller than the opening in the radial direction, the connecting selvage portion cannot be separated from the gap formed between the two. Preferably, the movement of the floating positioning portion can be further prevented by matching the width of the floating positioning portion with the opening in the radial direction of the axial through area.

Preferably, the portion of the floating positioning portion inserted into the positioning groove contacts the connecting selvage portion or the connecting selvagement portion in the direction toward the inside in the radial direction.

The floating positioning portion can prevent the connecting selvage portion from coming off, but the thickness (diameter direction size) of the floating positioning portion and the connecting selvage portion and the depth of the positioning groove do not have a corresponding relationship. When the outer sheath tube wraps around the outer circumference of the fixed head, the floating positioning section overlaps the outer wall of the connecting selvage. When the thickness of the floating positioning portion and the connecting selvage portion is larger than the depth of the positioning groove, the floating positioning portion abuts inside the connecting selvage portion along the radial direction. In the opposite case (ie, when the thickness of the floating positioning portion and the connecting selvage portion is not greater than the depth of the positioning groove), contact is formed but no large binding force is formed. In both cases, the floating positioning portion can limit the position of the connecting selvage portion. In a preferred embodiment, the effect of limiting can be ensured even when the axial force is large or the outer sheath tube is deformed by forming the contact relationship.

Preferably, in the mounted state, the floating positioning portion is equal to or higher than the outer wall of the fixed head in the radial direction.

Since the floating positioning portion is not lower than the outer wall of the fixed head in the radial direction, it is possible to avoid forming an extra gap between the floating positioning portion and the outer sheath tube. As a result, the inner wall of the outer sheath tube can be brought into close contact with the floating positioning portion, and the connecting ear portion can be brought into close contact with the positioning portion of the fixed head.

In the present invention, the portion of the floating positioning portion to be connected to the connecting ear portion can be extended in a straight line or a curved line.

When both sides of the floating positioning part come into contact with a predetermined side of the positioning groove, the width of the floating positioning part extending into a curve is appropriately narrowed, and when the feeding device is released, it is bent outward to facilitate the connecting selvage portion. It is possible to prevent the connecting ears from being easily released.

In the present invention, the portion to be connected to the connecting selvage portion of the floating positioning portion can be extended to the same width or non-same width.

In the circumferential direction, the floating positioning portion and the positioning portion include an area where at least a part thereof overlaps.

In the present invention, the portion to be connected to the connecting selvage portion of the floating positioning portion is stretched to the same thickness or non-same thickness. The portion connected to the connecting selvage portion of the floating positioning portion can be extended in a straight line or a curved line, but the portion connected to the connecting selvage portion of the floating positioning portion has a non-same width and / or a non-same thickness. You can also do it. By changing the width and thickness, the local strength can be controlled, the position can be determined, and the connecting ear can be released.

Preferably, a smooth outer peripheral surface is formed at the end of the floating positioning portion.

The floating positioning portion is expanded in the radial direction by the discharge of the feeding device. In order to prevent the end of the deployed floating positioning portion from damaging the inner wall of the blood vessel, the end can be smooth contoured, such as spherical or chamfered.

Preferably, the floating positioning portions are 2, 3 or 4 evenly arranged in the circumferential direction.

Preferably, each floating positioning portion is formed to have the same length or a non-same length.

When the floating positioning portions are formed to have non-equal lengths, the positions of the ends of the floating positioning portions can be different. For example, the end of at least one floating positioning portion may be extended to a position aligned with the far end side of the fixed head, and the end of at least one floating positioning portion may be extended to the far end side of the mounting position of the feeding device. it can.

There are a plurality of the floating positioning portions, and the plurality of floating positioning portions can be mounted at the same time or back and forth.

Preferably, the number of floating positioning portions is plurality, and the plurality of floating positioning portions can be converted from the mounted state to the released state at the same time or before and after.

The timing at which the floating positioning portion is completely wrapped in the outer sheath tube can be regarded as the mounting state, and the timing at which the floating positioning portion is completely exposed can be regarded as the release state. When the positions of the far ends of the plurality of floating positioning portions in the axial direction are different, the plurality of floating positioning portions are mounted in the front-rear direction. That is, a plurality of floating positioning portions are converted back and forth from the mounted state to the released state. When the positions of the far ends of the plurality of floating positioning portions match in the axial direction, the plurality of floating positioning portions are in the mounted state at the same time. That is, a plurality of floating positioning portions are simultaneously converted from the mounted state to the released state.

Preferably, the floating positioning portions are three having the same length, and all of them have a strip-like structure.

Preferably, the floating positioning portion has a hollow or solid structure.

Preferably, the floating positioning portion is in the form of a solid strip.

Since the floating positioning portion has a strip-like structure, it is possible to save the occupied space in the radial direction of the mounting position of the feeding device and reduce the external size after compression.

Preferably, in the size of the floating positioning portion, the length is 10 mm to 80 mm, the width is 1 to 2 mm, and the thickness is 0.2 to 0.5 mm.

Preferably, the floating positioning portion is fixedly connected to a predetermined part by a method of bonding, binding, locking, welding or integrally molding.

One end of the floating positioning portion is a start end, the other end is an end, and the central portion is an extension end. The starting end is located at the tail of the near end of the fixed head or at the connection between the tail and the internal sheath tube and is fixedly connected to a predetermined component by a method of adhesion, binding, locking, welding or integral molding. The floating positioning portion extends from the start end to the far end, and in a natural state, the start end of the floating positioning portion is fixed, and the stretched end and the end are developed in the axial direction of the core tube.

Preferably, a smooth surface and / or a smooth coating layer is formed on at least one of the site to be bonded to the outer sheath tube of the floating positioning portion and the site to be bonded to the stent of the floating positioning portion. ..

Preferably, the material of the floating positioning portion is PTFE (Poly tetra fluoroethylene).

Preferably, a fixed guide located on the inner wall of the outer sheath tube and extending axially is further formed.

One surface of the fixed guide portion is fixed to the tubular inner wall at the far end of the outer sheath tube (the direction in which the feeding device is separated from the user side), and the fixed guide portion extends in the axial direction of the tubular inner wall of the outer sheath tube. In the process of storing and releasing the feeding device by the external sheath tube, the feeding device comes into direct contact with the fixed guide portion located inside the tubular shape of the external sheath tube, and the fixed guide portion forms a flat rail. This allows the delivery device to be controlled quickly and accurately.

The fixed guide portion and the inner wall of the outer sheath tube can be connected by a plurality of fixed points which are partially contacted, wholly connected, or formed at intervals. Since the fixed guide portion reciprocates together with the outer sheath tube, it is preferable to fix at least both ends of the fixed guide portion in the axial direction to the inner wall of the outer sheath tube. It is possible to avoid the formation of obstruction due to bending.

Prior to surgery, the feeding device is housed in an external sheath tube so that the fixation guide is in close contact with the feeding device. When the feeding device is released, friction is created by the fixed guide forming a flat rail between the tubular inner wall of the outer sheath tube and the feeding device (one side approaching the feeding device). It can be reduced and the release and control of the delivery device can be facilitated.

Preferably, the floating positioning portion and the fixed guide portion are alternately arranged in the circumferential direction.

The positions of the fixed guides and the positioning grooves on the fixed head are alternately arranged. That means that the floating positioning part and the fixed guide part are arranged alternately.

Preferably, the terminal of the floating positioning portion and the axial position of the fixed guide portion on the far end side coincide with each other or are arranged alternately.

Preferably, the fixed guides are 2, 3 or 4 evenly arranged in the circumferential direction.

Preferably, each fixed guide is formed to have the same or non-same length.

Preferably, the fixed guides are three of the same length, all of which have a strip-like structure.

Preferably, the fixed guide has a hollow or solid structure.

Preferably, the fixed guide is in the form of a solid strip.

Since the fixed guide portion has a strip-like structure, it is possible to save the occupied space in the radial direction of the mounting position of the feeding device and reduce the external size after compression.

Preferably, in the size of the fixed guide portion, the length is 10 mm to 80 mm, the width is 1 to 2 mm, and the thickness is 0.2 to 0.5 mm.

Preferably, the length of the fixed guide portion is 60 mm to 80 mm.

In the present invention, the shapes and sizes of the floating positioning portion and the fixed guide portion can be different. For example, it can be a hollow or solid strip structure. The shape of the cross section is preferably strip-shaped, and the direction of the strip-shaped thickness can be the diameter direction of the outer sheath tube.

In order to easily control the release and recovery of the stent, the frictional force between the stent and the outer sheath tube can be reduced by reducing the contact area between the stent and the outer sheath tube, and the floating positioning part and the fixed guide part can be reduced. The size of can be selected appropriately.

Preferably, the fixation guide is secured to the inner wall of the outer sheath tube by a method of adhesion, binding, locking, welding or integral molding.

Preferably, a smooth surface and / or a smooth coating layer is formed at a portion of the fixed guide portion to be coupled to the feeding device.

Preferably, the material of the fixed guide portion is PTFE (Poly tetra fluoroethylene).

In the present invention, the materials of the floating positioning portion and the fixed guide portion can be different. As a preferred material, a material having elasticity and biocompatibility can be selected. Specifically, the material of the prior art can be adopted.

In the present invention, the feeding device can be a feeding type heart valve membrane. Due to different applications, the delivery device can also be a vascular stent.

In order to ensure that the floating positioning portion and the fixed guide portion have appropriate elasticity and a small dynamic friction coefficient, PTFE (Poly tetrafluoroethylene) can be selected as their material. Preferably, the outer surface of the floating positioning portion and the fixed guide portion can be smoothed, or a smooth coating layer can be formed. As a material for a smooth coating layer, a hydrophilic monomer (monomer) or a high polymer (high polymer) having good lubricating properties, such as N, N-dimethylacrylamide (DMAA), acrylamide (acrylamide, AAm), n-vinylpyrrolidone (NVP) , Polyvinyl alcohol (PVA), polyacrylamide (PAAm), polyethylene glycol (PEG), etc. are selected, and the coating material is float-positioned by a coupling agent or a chemical method. It can be attached to the outer surface of the part or the fixed guide part.

It is a figure which shows the structure of the transport device of the transfer device which concerns on embodiment of this invention. It is a figure which shows the structure of the far end portion of the transport device of the transfer device which concerns on embodiment of this invention. It is a figure which shows the structure of the lock part. It is a figure which shows the structure of the end of a floating positioning part. It is a structural drawing which shows the state before release which the outer sheath tube completely encloses a feeding device. It is a structural drawing which shows the semi-release state which exposes a part of the feeding device by an external sheath tube. It is a figure which shows the discharge state which the external sheath tube completely exposes a feeding device (the near end of a feeding device in the drawing is not elastically deformed in the radial direction). It is a figure which shows the release state of a valvular stent (the near end of the feeding device in the drawing was elastically deformed in the radial direction). It is a structural drawing which shows that the short floating positioning part is adopted in the other embodiment of this invention. It is a structural drawing which shows that the feeding device is in the state before discharge when the short floating positioning part is adopted in the other embodiment of this invention. It is a structural drawing which shows that the feeding device is in a semi-release state. It is a figure which shows that the feeding device is in a discharge state when a short floating positioning part is adopted (the near end of the feeding device in the drawing is not elastically deformed in the radial direction). It is a figure which shows the discharge state of the feeding device (the near end of the feeding device in the drawing was elastically deformed in the radial direction). It is a structural drawing which shows that the floating positioning part in FIG. 7D is repositioned. It is a figure which shows the semi-release state of a feeding device. It is a phase diagram that a part of the floating positioning part is released when the heart valve membrane is released. It is a phase diagram that the feeding device is in the release state. It is a structural drawing which shows that the fixed guide part is further formed. It is a figure which shows the cross section of the outer sheath tube. It is a figure which shows the discharge state of the feeding device to which a floating positioning part and a fixed guide part are attached. It is a figure which shows the part which is connected with the fixed head of the connection ear part. It is a figure which shows that the connection selvage part of FIG. 11A is restricted by the floating positioning part in the wearing state. It is a figure which shows the part which is connected with the fixed head of other connecting ears. It is a figure which shows that the connection selvage part of FIG. 12A is restricted by the different floating positioning part in the wearing state. It is a figure which shows that the connection selvage part of FIG. 12A is restricted by the different floating positioning part in the wearing state. It is a figure which shows that the connection selvage part of FIG. 12A is restricted by the different floating positioning part in the wearing state. It is a figure which shows that the other connecting selvage portions are restricted by different floating positioning portions. It is a figure which shows that the other connecting selvage portions are restricted by different floating positioning portions. It is a figure which shows that the other connecting selvage portions are restricted by different floating positioning portions. It is a figure which shows that the other connecting selvage portions are restricted by different floating positioning portions.

Hereinafter, the technical matters of the examples of the present invention will be described in more detail and sufficiently with reference to the drawings of the examples of the present invention. The following examples are only partial examples of the present invention, and do not show all the examples. When referring to the examples of the present invention, engineers in this art can come up with other examples without creative research, and of course they are included in the present invention. Is.

One or more drawings may be referenced to illustrate embodiments of the invention in more detail. The matters or examples shown in the drawings do not limit the scope of the technical matters, the examples described or the preferred embodiments of the present invention.

Note that a module being "tied" to another module means that the module is either directly tied to another module or indirectly tied by an intermediate module. When a module is "mounted" on another module, it means that the module is mounted directly on the other module or indirectly by an intermediate module.

Unless otherwise stated, technical or scientific terms used in the text refer to the meanings of terms commonly used by engineers in this art. The text or terms used in the present invention describe specific examples of the present invention and do not limit the present invention.

In the text, the near end refers to one end of the transport device approaching the user, and the near end refers to one end of the transport device away from the user. A valvular stent will be described as an example of the feeding device of this embodiment.

Referring to FIGS. 1 and 2, the transport device of the feeding device of the present invention includes a guide head 2, a core tube 7, and a floating positioning unit 1 (the floating positioning unit 1 is a near-end start end portion 13). Includes the extension step 12 and the far end 11), a fixed head 3, an internal sheath tube 4, an external sheath tube 5, and an operating handle 6.

Both the guide head 2 and the fixed head 3 are fixed on the core tube 7, the guide head 2 is located at the farthest end of the core tube 7, and the fixed head 3 is attached to the far end of the core tube 7. Has been done. A mounting position of the feeding device is formed between the guide head 2 and the fixed head 3, and a positioning portion 30 to be coupled to the connecting ear portion of the feeding device is formed on the outer wall of the fixed head 3. The connecting ear portion 81 of the feeding device is at least a part of a structure for connecting and connecting the feeding device and the positioning portion 30. The outer sheath tube 5 is located on the outer periphery of the mounting position of the feeding device and can slide in the axial direction, and both the core tube 7 and the near end of the outer sheath tube 5 are connected to the operation handle 6, and the operation handle 6 is connected. Therefore, it is possible to control the outer sheath tube 5 from sliding in the axial direction with respect to the core tube 7. The internal sheath tube 4 may or may not be attached depending on the demand. The inner sheath tube 4 is mounted on the core tube 7 and located near the fixed head 3, and the inner sheath tube 4 normally does not move axially with the outer sheath tube 5.

The core tube 7 can be composed of one component or two components that are inserted and fixed. By locating the insertion position within the fixed head 3, the strength of the connection and the flatness of the outer surface can be ensured.

The floating positioning unit 1 of FIG. 1 has three pieces having the same length, and when the outer sheath tube 5 is not bound, the floating positioning unit 1 is in a released state and stretches to a natural state.

Referring to FIG. 2, each portion of the floating positioning portion 1 is formed with a start end portion 13, an extension stage 12, and an end end 11, respectively. The start end portion 13 is the near end of the floating positioning portion. The start end portion 13 is fixed on the core tube 7 and is located on the near end side of the head tail portion fixing portion 32. As shown in the drawing, the starting end 13 is located between the internal sheath tube 4 and the head and tail fixing portion 32. The positioning portion of this embodiment is a positioning groove, and a positioning groove 33 is formed on the outer periphery of the fixed head 3. Since it is necessary to connect the positioning groove and the connecting selvage of the feeding device, the position and shape of the positioning groove correspond to the position and shape of the connecting selvage. The drawings show three positioning grooves, which are arranged axially intersecting. For example, the positioning groove 31 and the positioning groove 33 can be referred to. In order to prevent the floating positioning portion 1 from being stretched, it is preferable that the positioning groove has a structure penetrating in the axial direction. When the valvular stent is released, the radial outside of the positioning groove is left open to ensure that the connecting selvages are separated from the positioning groove along the radial outside. That is, the outside of the positioning groove in the radial direction is in an open state. The floating positioning portion 1 is located in the diametrical opening area of the positioning portion 30, and seals all or a part of the diametrical opening area of the positioning portion 30. As a result, the connecting selvage portion 81 is prevented from moving to the outside and separating from the positioning portion. As a result, the positioning groove 33 of this embodiment is formed.

The positioning groove in the drawing penetrates in the axial direction, and wings extending outward and corresponding to the T-shaped connecting ear portion are formed on both sides thereof. When the floating positioning unit 1 extends to the far end, the floating positioning unit 1 passes through the axial through area of the predetermined positioning groove and extends to the far end side of the mounting position of the feeding device. The floating positioning portion 1 in FIG. 2 is put into a no-load state, and the end 11 extends along the axial direction to the outer circumference of the guide head 2.

In FIG. 2, when the floating positioning portion is deployed in the axial direction, its far end extends to the portion of the guide head 2. When the floating positioning unit is coupled to the feeding device, it can serve as a guide by acting as a rail between the feeding device and the external sheath tube. When unconstrained by the outer sheath tube, the far end of the floating positioning portion is preferably bent outward in the radial direction and unfolded (see FIG. 1). Thereby, the discharge of the feeding device can be ensured and unexpected diametrical interference can be prevented. The shape of the floating positioning portion can be determined in advance. For example, the outer sheath tube can be shaped to expand outward in the radial direction when it is in the released state. At least a part of the floating positioning portion may have a deformable structure. The deformable structure can be composed of an elastic material and / or a hinge structure.

The start end portion 13 of the floating positioning portion can be fixed by a method of bonding, binding, locking, welding, or integrally molding. As an adhesive material, a corrosion-resistant cross-linking agent having biocompatibility can be used. As the binding, a binding wire having good flexibility and corrosion resistance can be used.

In the welding method, a lock portion made of an alloy material can be connected to a head tail fixing portion or a core tube, and then the starting end can be fixed by the locking portion. For example, referring to FIG. 3, the start end 13 of the floating positioning portion 1 can be fixed in the lock portion 14 made of stainless steel. The drawings show that a portion of the stretching step 12 and the locking portion 14 are connected onto the fixed head 3 or the core tube 7 by a welding method.

The feeding device shown in FIGS. 1 and 2 (the feeding type heart valve membrane is not shown in this drawing, that is, the floating positioning unit 1 is in a no-load state) is fitted with the feeding type heart valve membrane. Then, the floating positioning unit becomes a load state. That is, the floating positioning portion exerts an acting force on the connecting portion of the feeding device by binding the outer sheath tube. For example, it is possible to prevent the connecting ear portion of the feed-in type heart valve membrane from separating from the positioning groove. The floating positioning unit further includes a release state. When the feeding device is released from the external sheath tube and the floating positioning portion, it is removed that the external sheath tube exerts an acting force on the connecting portion of the feeding device by the floating positioning portion. For example, when the external sheath tube is removed and the delivery type heart valve membrane is released, the external sheath tube is removed from exerting an action force on the connecting ear part of the delivery type heart valve membrane by the floating positioning portion, and the valve membrane stent is connected. Discharge the ears radially and away from the positioning groove.

The floating positioning unit 1 has a strip-shaped solid or hollow structure. The floating positioning unit 1 of this embodiment has a solid strip shape. In order to prevent the pointed from being formed at the end 11, the edge portion of the end 11 can be formed into an arc shape (see FIG. 4).

Each floating positioning portion 1 has a length of 10 mm to 80 mm, a width of 1 to 2 mm, and a thickness of 0.2 to 0.5 mm. When the floating positioning portion 1 is extended to the maximum length, it is ensured that the entire floating positioning portion 1 is housed in the outer sheath tube 5 and the end of the floating positioning portion 1 is extended to the far end side of the valve membrane stent 8. Therefore, it is necessary that the length of the floating positioning portion 1 under the mounted state covers the entire valve membrane stent 8. Thereby, it is possible to prevent the outer sheath tube 5 from directly contacting the valve membrane stent 8 when advancing or retracting.

See FIGS. 5A-5D. In order to ensure that the floating positioning unit 1 has a small dynamic friction coefficient, PTFE (Poly tetrafluoroethylene) can be selected and manufactured as the material of the floating positioning unit 1. In the drawings, the length of each floating positioning portion 1 is 65 mm, the width thereof corresponds to the width of the positioning groove of the fixed head 3, and the thickness thereof is 0.5 mm. When the floating positioning portion 1 is in the contracted state, the three floating positioning portions 1 are further extended to the far end side along the positioning groove corresponding to the through position in the axial direction. The valve membrane stent 8 includes three T-shaped connecting ears, and a positioning groove is formed in a T-shape and is axially penetrated in order to correspond to the connecting ears. That is, it is formed in a cross shape. In order to ensure the effect of positioning, the axial through area of the positioning groove is completely sealed by the predetermined floating positioning portion 1. That is, the width of the floating positioning unit 1 corresponds to the width of the through area in the axial direction. When the penetration area does not extend the same width along the axial direction, the width of the floating positioning portion 1 corresponds to at least the minimum width of the penetration area, so that a part or the whole of the floating positioning portion is housed in the positioning groove. Can be ensured. Since the outer side of the floating positioning portion 1 is slightly higher than the outer peripheral surface of the fixed head 3, friction between the outer peripheral surface of the fixed head 3 and the inner wall of the outer sheath tube 5 can be reduced.

See FIGS. 5A-5D. 5A and 5B show the mounted state of the feeding device, FIG. 5A shows the pre-release state in which the external sheath tube 5 completely wraps the feeding device 8, and FIG. 5B is a half that exposes a part of the feeding device 8. The release state is shown, and FIGS. 5C and 5D show the release state of the feeding device. In FIG. 5C, when the external sheath tube completely exposes the valvular stent, the near end of the valvular stent is in a self-expanding state but does not undergo radial elastic deformation. It's a very short moment. The near end of the valvular stent in FIG. 5D shows a fully elastically deformed release state. When the feeding device is in the mounted state, the floating positioning unit 1 restricts the connecting selvage portion from detaching from the positioning unit.

As shown in FIG. 5A, when the valve membrane stent 8 is attached to the transport device, the floating positioning unit 1 wraps the valve membrane stent 8 from the fixed head 3 and then stores them in the outer sheath tube 5. When the feeding device is in the mounted state, the floating positioning portion 1 abuts on the inner wall of the outer sheath tube along the radial direction, and the floating positioning portion 1 has the connecting ear portion 81 from the positioning groove 33 along the radial direction in the radial direction. Restrict withdrawal.

As shown in FIG. 5B, in the process of releasing the valve membrane stent 8, the floating positioning portion 1 is sequentially withdrawn while avoiding direct contact of the outer sheath tube 5 with the valve membrane stent 8. The end 11 of the floating positioning portion 1 and the extension stage 12 are deployed by deploying the valve membrane stent 8. In the process of being released, the end 11 of the floating positioning portion changes from the state of being in contact with the valve membrane stent 8 to the deployed state. The valve membrane stent 8 is released by retracting the outer sheath tube 5 in the direction of the floating positioning portion 1. The start end 13 of the floating positioning portion 1 abuts and is fixed to the fixed head 3, and the extension step 12 adjacent to the start end 13 receives the binding force of the start end 13. When the connecting selvage portion of the valve membrane stent 8 is inserted into the positioning groove 33 of the fixed head 3, the near end of the floating positioning portion 1 abuts on the positioning groove 33 and applies a radial pressure to the connecting ear portion of the valve membrane stent 8. .. As a result, when the valve membrane stent 8 is released, the connecting ear portion can be prevented from being detached from the positioning groove 33 of the fixed head 3 early and the valve membrane stent 8 is suddenly released. Further, in the process of releasing the valvular stent 8, if the position of the valvular stent is deviated and it is necessary to reattach it, a binding force is applied to the connecting ear portion in the positioning groove 33 by the near end of the floating positioning portion 1. The outer sheath tube 5 can be ensured to move forward along the floating positioning portion 1, and the valve membrane stent 8 can be recovered by accommodating the released valve membrane stent 8.

In FIG. 5C, the projections formed in the axial region of the outer sheath tube by the near ends of the positioning grooves 33 of the outer sheath tube 5 and the fixed head 3 are arranged intersecting, and the floating positioning portion 1 is bound by the outer sheath tube. It does not limit the radial movement of the connecting ear of the valvular stent. That means that the force exerted by the floating positioning portion 1 on the connecting selvage portion of the valve membrane stent 8 is eliminated. That is, the floating positioning unit 1 is in the released state, and the valve membrane stent 8 can be detached from the positioning groove 33 after being deployed. The connecting selvage portion in FIG. 5C is not elastically deformed in the radial direction, but is in a state where it can be elastically deformed in the radial direction.

In FIG. 5D, at the near end of the valvular stent, the connecting selvage portion 81 is expanded in the radial direction and the floating positioning portion 1 is separated from the connecting selvage portion.

Referring to FIG. 6, in another embodiment, the floating positioning portion 1 has a short axial length and its end can be aligned with the far end of the fixed head 3.

In FIGS. 1, 2 and 5A to 5D, the floating positioning unit 1 having a long length is adopted. When the floating positioning unit 1 is in a load state, the feeding device is restricted. For example, it limits the radial movement of the connecting selvage of the valvular stent and is coupled to the connecting selvage to improve stability. Further, by forming a flat rail between the valve membrane stent 8 and the outer sheath tube 5, the frictional force when the two come into contact with each other is reduced. By contacting the floating positioning portion 1 when the outer sheath tube 5 moves forward or backward, the force operated by the doctor can be reduced, and the release and recovery of the valvular stent 8 can be accurately controlled.

The floating positioning unit 1 in FIG. 6 has three and is in the form of a solid strip. The floating positioning unit 1 is manufactured of PTFE (Poly tetra fluoroethylene), the start end of the floating positioning unit 1 is fixed to the near end tail of the fixed head 3 by an adhesive method, and the end of the floating positioning unit 1 is fixed. Align with the far end of the fixed head 3. That is, the end of the floating positioning portion 1 covers at least the connecting selvage portion and the connecting selvage portion is housed in the positioning groove. The width of the floating positioning portion 1 coincides with the width of the through area in the axial direction of the positioning groove 33, and the thickness thereof is 0.5 mm.

See FIGS. 7A-7E. In another embodiment, the outer sheath tube 5 comprises a pre-release state that completely encloses the feed device 8, a semi-release state that exposes a portion of the feed device 8, and a release state that completely exposes the feed device 8. To do. When the outer sheath tube 5 is in the pre-release state and the semi-release state, the floating positioning unit 1 is in the load state.

In this example, the valvular stent 8 comprises a connecting ear 81. When the valve membrane stent 8 is attached to the transport system, the length of extension of the floating positioning portion 1 corresponds to the position of the far end of the fixed head 3, and the end thereof is coupled to the inside of the positioning groove 33 of the fixed head. It only contacts the connecting ear. When the valvular stent 8 is delivered into the human body and released, if the external sheath tube 5 is removed, the valvular stent 8 is gradually released. At that time, the connecting selvage portion 81 of the valve membrane stent 8 is coupled into the positioning groove 33 of the fixed head, and the connecting selvage portion is stably housed in the positioning groove 33 by the contraction force of the start end of the floating positioning portion 1. , The released valve membrane stent 8 exerts an expanding force on the connecting selvage portion to prevent the valve membrane stent from being rapidly and completely released.

When the floating positioning portion 1 having a short length is adopted, it is possible to avoid affecting the release of the valvular stent and unnecessary binding. The length of the floating positioning portion 1 can be extended to the axial central region of the valvular stent 8. That is, the length of the floating positioning portion 1 does not exceed the axial maximum dimension of the valve membrane when the valve membrane is completely released. For example, it does not exceed point A in FIG. 7H.

FIG. 7A shows the pre-release state of the outer sheath tube 5.

In FIG. 7B, when the valvular stent 8 is delivered into the human body and released, the valvular stent 8 is gradually released when the outer sheath tube 5 is removed. At that time, the connecting selvage portion 81 of the valve membrane stent 8 is coupled into the positioning groove 33 of the fixed head, and the connecting selvage portion is stably housed in the positioning groove 33 by the contraction force of the start end of the floating positioning portion 1. Therefore, it is possible to prevent the valvular stent 8 from being rapidly and completely released by exerting an expanding force on the connecting selvage portion by the released valvular stent 8.

In FIG. 7C, when the outer sheath tube 5 is removed, the projected area on the axis of the outer sheath tube 5 and the outer sheath tube of the positioning groove 33 is displaced, and the floating positioning portion 1 does not bind the connecting selvage portion 81. The floating positioning unit 1 eliminates the transmission of the acting force to the valve membrane stent 8. That is, the floating positioning unit 1 is in the released state and allows the valve membrane stent 8 to separate from the positioning groove 33. In the momentary state of FIG. 7C, the connecting selvage portion is in a momentary state in which it is not discharged in the radial direction but is about to be discharged in the radial direction.

The mounted state of the present invention means a state in which the connecting portion of the feeding device is coupled to the positioning portion. Specifically, it means a state in which the feeding device is coupled to the positioning unit. In the release state, the connecting part of the feeding device can be separated from the positioning part, but it does not only mean that the feeding device is completely discharged, and only the connecting part connected to the positioning part can be released. It can be pointed out that it has become. In the portion not coupled to the positioning part, part or all can be released and expanded in the radial direction.

In FIG. 7D, the connecting selvage portion 81 is driven so that the floating positioning portion 1 capable of being deformed in the radial direction is elastically deformed in the radial direction. In that case, the floating positioning unit 1 is also bent outward. In FIG. 7E, the floating positioning unit 1 approaches the fixed head 3 side and is in the restored state.

In another embodiment, reference is made to FIGS. 7F, 7G, and 7H. In order to ensure that the floating positioning unit 1 has a small dynamic friction coefficient, PTFE (Poly tetrafluoroethylene) can be selected and manufactured as the material of the floating positioning unit 1. In the drawings, the length of each floating positioning portion 1 is 15 mm, and the floating positioning portion slightly protrudes from the fixed head of the stent. The width of each floating positioning portion 1 corresponds to the width of the positioning groove of the fixed head 3, and the thickness thereof is 0.5 mm. When the floating positioning portion 1 is in the contracted state, the three floating positioning portions 1 are further extended to the far end side along the positioning groove corresponding to the through position in the axial direction. The valve membrane stent 8 includes three T-shaped connecting ears 81, and a positioning groove is formed in a T-shape and is axially penetrated in order to correspond to the connecting ears. That is, it is formed in a cross shape. In order to ensure the effect of positioning, the axial through area of the positioning groove is completely sealed by the predetermined floating positioning portion 1. That is, the width of the floating positioning unit 1 corresponds to the width of the through area in the axial direction. When the penetration area does not extend the same width along the axial direction, the width of the floating positioning portion 1 corresponds to at least the minimum width of the penetration area, so that a part or all of the floating positioning portion is housed in the positioning groove. Can be ensured. Since the outer side of the floating positioning portion 1 is slightly higher than the outer peripheral surface of the fixed head 3, friction between the outer peripheral surface of the fixed head 3 and the inner wall of the outer sheath tube 5 can be reduced.

When the valvular stent 8 is mounted on the transport device, the floating positioning portion 1 wraps the valvular stent 8 and the two are housed together in the outer sheath tube 5. That is, the outer sheath tube completely wraps the feeding device in the pre-release state, and the floating positioning unit 1 is in the mounted state in the pre-release state. When the valvular stent 8 is released, in the direction of arrow M shown in FIG. 7F, the outer sheath tube 5 is in the floating positioning portion 1 (since the floating positioning portion in the drawing is housed in the outer sheath tube 5, it is shown in the drawing. Withdrawal to lubrication along (not shown), the floating positioning unit 1 is put into operation. When the connecting selvage portion 81 is housed in the outer sheath tube 5, the floating positioning portion 1 abuts on the connecting selvage portion 81 by being bound by the outer sheath tube 5, and prevents the connecting selvage portion 81 from being ejected. be able to.

As shown in FIG. 7G, when the outer sheath tube 5 is further retracted in the direction of the arrow M, the far end 101 of the floating positioning portion 1 is not bound by the outer sheath tube 5, and the stretching stage 102 and the valve membrane are not bound. Since the connecting selvage portion of the stent is still housed in the outer sheath tube 5, the extension step 102 exerts an acting force on the connecting selvage portion 81. By receiving the acting force of the extension step 102, the connecting selvage portion 81 is prevented from forming a strong expanding force when the stent is expanded and released, and the connecting selvage portion is the positioning groove of the fixed head 3 of the stent. It is possible to ensure stable coupling within 33. That is, the extension stage 102 exerts an acting force on the connecting selvage portion 81 to apply a pressure in the radial direction to the connecting selvage portion 81 of the valve membrane stent, ensuring that the connecting selvage portion of the valve membrane stent is stably bonded, and the stent. Prevents the formation of a strong expansive force when the stent is expanded and released, ensures that the connecting selvage is stably coupled within the positioning groove 33 of the stent's fixed head 3, and the connecting selvage. Can prevent the stent from being completely released away from the positioning groove of the fixed head.

At that time, if the release position of the valve membrane stent is not accurate, the stent can be recovered by advancing the outer sheath tube 5 (along the direction opposite to the arrow M) and the valve membrane can be released again. If the release position of the valvular stent is accurate, the outer sheath tube 5 is further retracted in the direction of arrow M. At that time, as shown in FIG. 7H, since the end 101 of the floating positioning portion 1 and the extension stage 102 are not bound by the outer sheath tube 5, the end 101 and the extension stage 102 of the floating positioning portion 1 deploy the valve membrane stent 8. Can be expanded by. At that time, the floating positioning portion 1 is inactive and does not exert an acting force on the connecting selvage portion 81, so that the valve membrane stent 8 can be deployed.

The operating state of this specification means that the floating positioning unit 1 is in the mounted state, and the non-operating state means that the floating positioning unit 1 is in the releasing state. When the feeding device begins to be in the release state, it is removed that the external sheath tube exerts an acting force on the connecting part of the feeding device by the floating positioning portion. For example, when the external sheath tube is removed and the delivery type heart valve membrane is released, the external sheath tube is removed from exerting an action force on the connecting ear part of the delivery type heart valve membrane by the floating positioning portion, and the valve membrane stent is connected. Discharge the ears radially and away from the positioning groove.

If it is discovered that the release position of the valvular stent is not accurate during the release process, the valvular stent 8 is moved into the external sheath tube 5 by advancing the external sheath tube 5, that is, by advancing in the direction opposite to the arrow M. Can be stowed again for storage and a second release.

Comparing the prior arts, the present invention finds that the valvular stent can be stably recovered and the release position of the valvular stent is not accurate when the valvular stent is released. By storing it in 5, the second positioning and collection can be performed. The stable posterior tensile force is the point at which the valvular stent is re-accommodated in the external sheath tube 5. The floating positioning portion 1 acts like a spacer to ensure that the connecting selvage portion 81 is stably housed in the positioning groove 33, and the movement of the external sheath tube provides an effective recovery force for the valve membrane stent. , The valvular stent can be housed in an external sheath tube.

In the process of release, even if a part of the feeding device is exposed (that is, the outer sheath tube 5 is in the semi-release state), the floating positioning unit 1 is still in the mounted state.

If the current release position is accurate, the outer sheath tube 5 is further retracted in the direction of arrow M. At that time, as shown in FIG. 7H, since the end 101 of the floating positioning portion 1 and the extension stage 102 are not bound by the outer sheath tube 5, the end 101 and the extension stage 102 of the floating positioning portion 1 deploy the valve membrane stent 8. Can be expanded by. At that time, the floating positioning portion 1 is in the released state and does not exert an acting force on the connecting selvage portion 81, so that the valve membrane stent 8 can be released. When the valvular stent is completely released, the radial pressure exerted by the floating positioning part on the connecting selvage portion 81 disappears at the same time as the withdrawal of the outer sheath tube 5, thus giving new interference to the well-released valvular stent. Can be prevented and the movement of the valvular stent can be effectively prevented.

See FIGS. 8, 9 and 10. In another embodiment, a fixed guide portion 10 is further formed on the inner wall at the far end of the outer sheath tube 5.

The drawing shows a floating positioning portion 1, a guide head 2, a fixed head 3, an inner sheath tube 4, an outer sheath tube 5, and a valve membrane stent 8, and a fixed guide portion 10 is further attached to the inner wall of the outer sheath tube 5. It is formed. The fixed guide portions 10 are three having the same length, and they are evenly arranged in the circumferential direction. By fixing the fixation guide portion 10 to the tubular inner wall at the far end of the outer sheath tube 5, a flat rail can be formed between the valve membrane stent 8 and the outer sheath tube 5.

By arranging the circumferential position of each fixed guide portion 10 and the positioning groove of the fixed head 3 (arranged on the circumference of the floating positioning portion 1) intersectingly, the valve membrane stent 8 is attached to the outer sheath tube 5. When retracting, the near end of the fixed guide portion approaches the fixed head 3, and its position intersects the positioning groove, respectively.

The fixed guide portion 10 has a solid strip shape, its length is 10 mm to 80 mm, its width is 1 to 2 mm, and its thickness is 0.2 to 0.5 mm. The length of the fixed guide portion 10 and the axial length of the valve membrane stent 8 of this embodiment are about 60 mm.

The fixing guide portion 10 can be fixed to the inner wall of the outer sheath tube 5 by an adhesive, binding, locking, welding or integrally molding method. The material of the fixed guide portion 10 is PTFE (Poly tetrafluoroethylene), and a smooth surface and / or a smooth coating layer is formed at a portion of the fixed guide portion 10 that is bonded to the feeding device 8. In a preferred embodiment, the fixed guide portion 10 and the inner wall of the outer sheath tube 5 are integrally formed, and the fixed guide portion 10 is a protruding portion protruding from the inner wall of the outer sheath tube 5 and has a smooth surface on the fixed guide portion 10. And / or a smooth coating layer is formed.

The fixed guide can accommodate floating positioning parts of different lengths. The fixed guide can include, but is not limited to, the floating positioning section shown in FIGS. 1 and 2 and the short floating positioning section shown in FIGS. 6 and 7A-7H. Specifically, with reference to FIG. 10, FIG. 10 is a diagram showing a release state of the mounting device on which the floating positioning portion and the fixed guide portion are mounted. The outer sheath tube 5 in FIG. 10 is retracted to a position where the floating positioning portion is completely exposed in order to better show the structure between the connecting selvage portion 81 of the valve membrane stent 8 and the floating positioning portion 1. At that time, the connecting selvage portion is not expanded in the radial direction, and is in a momentary state when it is about to be released in the radial direction.

Referring to FIG. 10, when the valvular stent 8 is released, the external sheath tube 5 is slidably contacted with the valvular stent 8 by the fixation guide 10. When the frictional force is very small, the stent can be gradually released by retracting the outer sheath tube 5.

When the external sheath tube 5 is retracted to the position of the fixed head 3, only the connecting ear portion of the valve membrane stent 8 is housed in the external sheath tube 5. At that time, the fixed guide portion 10 and the valve membrane stent 8 are completely separated, and the floating positioning portion 1 comes into close contact with the connecting selvage portion by binding the external sheath tube 5. When the outer sheath tube 5 is further retracted, the binding force exerted by the floating positioning portion 1 on the connecting selvage portion becomes smaller, so that the connecting selvage portion can be released. The valve membrane stent 8 can be gradually released by the smooth rail formed by the fixed guide portion 10 and the floating positioning portion 1 and the pressure in the radial direction. The outer sheath tube 5 is filled with a gap between the smooth rail formed by the fixed guide portion 10 and the floating positioning portion 1, thereby reducing the frictional force between the outer sheath tube 5 and the compressed valve membrane stent. It can be facilitated to release the valvular stent or re-store it in the sheath tube.

In another embodiment that further improves the present invention, a part of the floating positioning portion is mounted on the positioning groove / inside the positioning groove of the fixed head, so that the fixed ear portion of the stent expands in the radial direction from the positioning groove. You can limit your departure. When the other part of the floating positioning portion is attached to the outer peripheral wall of the fixed head, it acts like a rail, and the outer sheath tube can slide along the floating positioning portion. In a preferred embodiment, the farthest end of the floating positioning portion corresponding to the positioning groove is aligned with the fixed head, does not protrude from the farthest end of the fixed head, or protrudes slightly from the farthest end of the fixed head. be able to.

In the following examples, mainly the length and shape of the floating positioning portion and the method of connecting the connecting selvage portion and the fixed head will be further described. At least one of the above-described embodiments can be adopted as another component.

Referring to FIGS. 11A and 11B, the connecting selvage portion 81 is T-shaped, and the positioning portion on the fixed head 3 is a positioning groove 33. In the mounted state, the connecting selvage portion 81 is coupled into the positioning groove 33 having the corresponding shape, and the floating positioning portion 1 is tightly contacted on the connecting selvage portion 81 by binding the external sheath tube to be connected. It is possible to prevent the selvage portion 81 from separating from the positioning groove 33. In the process of releasing the stent, the positional limitation of the connecting selvage portion 81 is removed when the outer sheath tube is completely detached from the floating positioning portion 1.

Since the positioning groove 33 has an appropriate depth (the depth is not smaller than the thickness of the connecting selvage portion), the connecting selvage portion 81 can be coupled (inserted) in the positioning groove 33 in the radial direction.

In another preferred embodiment, the floating positioning portion 1 and the connecting selvage portion 81 can be superposed together in the positioning groove 33. Since the positioning groove 33 has an appropriate depth (the depth is the sum of the thicknesses of the connecting selvage portion and the floating positioning portion), the height in the radial direction of the floating positioning portion 1 under the mounted state and the fixed head The outer wall of 3 can be the same height.

With reference to FIGS. 12A-12D, the connecting selvage 81 is U-shaped, one side of the U-shaped opening is connected to the stent, and the U-shaped opening is sealed. The positioning portion on the fixed head 3 is a positioning protrusion 34, and the connecting ear portion 81 is coupled on the positioning protrusion 34 by its U-shaped structure, whereby the axial position can be determined. An insertion groove 35 is formed on the outer circumference of the positioning protrusion 34, that is, on the outer wall of the fixed head 3 in order to prevent the connecting ear portion 81 from protruding excessively to the outside in the radial direction. By superimposing the connecting ear portion 81 in the insertion groove 35, the height in the radial direction thereof and the outer wall of the fixed head 3 can be the same height.

In another preferred embodiment, the floating positioning portion 1 and the connecting selvage portion 81 can be superposed together in the insertion groove 35. Since the insertion groove 35 has an appropriate depth (the depth is the sum of the thicknesses of the connecting selvage portion and the floating positioning portion), the height in the radial direction of the floating positioning portion 1 under the wearing state and the fixed head The outer wall of 3 can be the same height.

In FIG. 12B, the floating positioning portion 1 has a fork structure, that is, a U-shaped structure. The non-fork type structure of the floating positioning portion 1 is fixed to the outside of the fixed head 3, and the far end of the fork structure extends to the outside of the connecting selvage portion 81 so as to overlap the connecting selvage portion 81.

In FIG. 12C, the floating positioning portion 1 has a single strip type structure, and the far end of the floating positioning portion extends to the outside of the connecting selvage portion 81 so as to overlap the connecting selvage portion 81.

In FIG. 12D, the floating positioning unit 1 can have a fork structure, for example a V-shaped or Y-shaped structure. The non-fork type structure of the floating positioning portion 1 is fixed to the outside of the fixed head 3, and the far end of the fork structure extends to the outside of the connecting selvage portion 81 so as to overlap the connecting selvage portion 81.

With reference to FIGS. 13A-13D, the drawings show that the connecting selvages are pushed by the floating positioning portions 1 having different lengths. When the feed-in type heart valve membrane is in the attached state, the floating positioning portion 1 is bound by the external sheath tube 5, and the connecting ear portion 81 determines the external position of the fixed head. In the example where the positioning portion on the fixed head is the positioning protrusion 34, at least a part of the floating positioning portion 1 on the far end side is superimposed on the connecting ear portion 81.

As shown in FIG. 13A, the far end side of the floating positioning portion 1 is superimposed on the connecting selvage portion 81, and the far end side of the floating positioning portion 1 does not extend to the positioning protrusion 34, and a small portion of the connecting selvage portion 81. Superimpose only on the area of.

As shown in FIG. 13B, the far end side of the floating positioning portion 1 overlaps the connecting selvage portion 81, and the far end side of the floating positioning portion 1 completely covers the positioning portion on the fixed head at least in the axial direction. That is, it reaches the far end side of the fixed head 3 beyond the positioning protrusion 34, faces one side of the far end in the axial direction, and overlaps the connecting ear portion 81 and the entire fixed head 3.

As shown in FIG. 13C, the far end side of the floating positioning portion 1 overlaps the connecting selvage portion 81, and the far end side of the floating positioning portion 1 exceeds the fixed head in the axial direction.

In FIG. 13D, the far end side of the floating positioning portion 1 is superimposed on the connecting selvage portion 81, and the far end side of the floating positioning portion 1 exceeds the fixed head in the axial direction to the maximum diameter of the feed-in type heart valve membrane. Will be sent. Since the fed-in heart valve membrane in the worn state is bound by the external sheath tube, the outer diameters of the fed-in type heart valve membrane are the same. Therefore, it can be understood that the maximum diameter portion is the maximum diameter portion under the emission state.

In the examples of the present invention, the use of the heart valve membrane stent by feeding it into the body has been described as an example, but engineers in this technical field not only use the delivery device of the present invention for the heart valve membrane stent. , Another feeder can be used as a mounting device by feeding it to another position on the body.

When each embodiment of the present invention includes a plurality of configurations, it goes without saying that a possible combination of these configurations is included even if there is no particular description. In addition, when a plurality of examples and modifications are shown, it goes without saying that possible combinations of configurations straddling these examples are included even if there is no particular description.

Although specific examples of the present invention have been described in detail above, the above-mentioned examples are merely examples of the present invention, and the present invention is not limited to the configuration of the examples. Engineers in this technical field can make design changes, improvements, etc. within the scope of the gist of the present invention, and even if there are such design changes, improvements, etc., they are of course included in the present invention. Is. The scope to be protected by the present invention is based on the scope defined by the claims.

Claims (43)

A guide head and a fixed head are fixed on the core tube including the core tube.
The guide head is fixed to the far end of the core tube and
The near end side of the core tube exceeds the fixed head, and the space between the guide head and the fixed head is the mounting position of the feeding device.
An easy-to-control transport device for which an external sheath tube capable of sliding in the axial direction is attached around the mounting position of the feed device.
A floating positioning portion is further included, the near end of the floating positioning portion is a start end provided so as to be immovable with respect to a fixed head or a core tube, and the far end is a transport device of a feeding device and an external sheath tube. Is the end that floats between
A positioning portion to be coupled to the connecting ear portion of the feeding device is formed on the outer wall of the fixed head, and when the feeding device is in the mounted state, the floating positioning portion is bound by the external sheath tube. An easy-to-control transport device for a feeding device, characterized in that the connection between the connecting selvage portion and the positioning portion is ensured. The transport device for an easy-to-control feeding device according to claim 1, wherein the starting end of the floating positioning portion is fixed to at least one of the fixed head or the core tube. The positioning portion is a positioning protrusion, and when the feeding device is in the mounted state, the connecting ear portion is coupled on the positioning protrusion, and the floating positioning portion is superimposed on the outside of the connecting ear portion to form a connecting ear. The transport device for an easy-to-control feeding device according to claim 1, wherein the coupling between the portion and the positioning portion is ensured. The positioning portion is a positioning groove, and when the feeding device is in the mounted state, the connecting selvage portion is coupled in a predetermined positioning portion, and the floating positioning portion is superimposed on the outside of the connecting selvage portion to cause the connecting selvage portion. The transport device for an easy-to-control feeding device according to claim 1, wherein the coupling between the selvage and the positioning unit is ensured. The transport device for an easy-to-control feeding device according to claim 4, wherein the number of the floating positioning unit and the number of positioning grooves are the same, and the positions in the circumferential direction have a one-to-one correspondence. A claim characterized in that the farthest end of the floating positioning portion is aligned with the farthest end of the fixed head, does not protrude from the farthest end of the fixed head, or slightly protrudes from the farthest end of the fixed head. Item 2. The transport device of the transfer device that is easy to control according to item 1. The easy-to-control feed-in according to claim 4, wherein the positioning groove penetrates in the axial direction, and a part or all of the portion to be coupled to the positioning groove of the floating positioning portion is inserted into the positioning groove. Equipment transport equipment. The transport device for an easy-to-control feeding device according to claim 7, wherein the axially penetrating area of the positioning groove is completely sealed by a floating positioning portion. The easy-to-control according to claim 4, wherein the portion of the floating positioning portion inserted into the positioning groove contacts the connecting selvage portion or abuts the connecting selvagement portion in a direction toward the inside in the radial direction. Transport device for delivery device. The transport device for an easy-to-control feeding device according to claim 7, wherein the floating positioning portion has the same height as the outer wall of the fixed head or is higher than the outer wall of the fixed head in the radial direction. The transport device for an easy-to-control feeding device according to claim 1, wherein the portion to be connected to the connecting selvage portion of the floating positioning portion extends in a straight line or a curved line. The transport device for an easy-to-control feeding device according to claim 11, wherein the portion to be connected to the connecting selvage portion of the floating positioning portion extends to the same width or a non-same width. The transport device for an easy-to-control feeding device according to claim 1, wherein a smooth outer peripheral surface is formed at the end of the floating positioning portion. The transport device for an easy-to-control feeding device according to claim 13, wherein the floating positioning units are 2, 3 or 4 evenly arranged in the circumferential direction. The transport device for an easy-to-control feeding device according to claim 14, wherein each floating positioning unit is formed to have the same length or a non-same length. The transport device for an easy-to-control feeding device according to claim 1, wherein the floating positioning unit has a hollow or solid structure. The transport device for an easy-to-control feeding device according to claim 16, wherein the floating positioning unit has a solid strip shape. The control according to claim 17, wherein the size of the floating positioning portion has a length of 10 mm to 80 mm, a width of 1 to 2 mm, and a thickness of 0.2 to 0.5 mm. Easy transfer device transport device. The transport device for an easy-to-control feeding device according to claim 1, wherein the floating positioning portion is fixedly connected to a predetermined part by a method of bonding, binding, locking, welding, or integrally molding. A smooth surface and / or a smooth coating layer is formed on at least one of the portion of the floating positioning portion to be connected to the outer sheath tube and the portion of the floating positioning portion to be connected to the stent. The transport device of the transfer device according to claim 1, wherein the control device is easy to control. The transport device for an easy-to-control feeding device according to claim 1, wherein the material of the floating positioning portion is PTFE (Poly tetrafluoroethylene). The transport device for an easy-to-control feeding device according to any one of claims 1 to 21, wherein a fixed guide portion located on the inner wall of the outer sheath tube and extending in the axial direction is further formed. .. The transport device for an easy-to-control feeding device according to claim 22, wherein the floating positioning unit and the fixed guide unit are alternately arranged in the circumferential direction. The transport device for an easy-to-control feeding device according to claim 22, wherein the terminal of the floating positioning portion and the axial position of the fixed guide portion on the far end side coincide with each other or are arranged alternately. The transport device for an easy-to-control feeding device according to claim 22, wherein the fixed guide portions are 2, 3 or 4 evenly arranged in the circumferential direction. The transport device of an easy-to-control feeding device according to claim 25, wherein each fixed guide portion is formed to have the same length or a non-same length. The transport device for an easy-to-control feeding device according to claim 22, wherein the fixed guide portion has a hollow or solid structure. The transport device for an easy-to-control feeding device according to claim 27, wherein the fixed guide portion has a solid strip shape. 28. The control according to claim 28, wherein the size of the fixed guide portion has a length of 10 mm to 80 mm, a width of 1 to 2 mm, and a thickness of 0.2 to 0.5 mm. Easy transfer device transport device. The transport device for an easy-to-control feeding device according to claim 29, wherein the length of the fixed guide portion is 60 mm to 80 mm. 22. The transport device for an easy-to-control feeding device according to claim 22, wherein the fixing guide portion is fixed to the inner wall of the outer sheath tube by an adhesive, binding, locking, welding or integrally molding method. 22. The transport device of the feed device that is easy to control according to claim 22, wherein a smooth surface and / or a smooth coating layer is formed at a portion to be coupled to the feed device of the fixed guide portion. .. The transport device for an easy-to-control feeding device according to claim 22, wherein the material of the fixed guide portion is PTFE (Poly tetrafluoroethylene). The transport device for an easy-to-control feeding device according to claim 1, wherein the feeding device is a feeding type heart valve membrane. The mounting state of the feeding device includes a pre-release state in which the external sheath tube completely wraps the feeding device and a semi-release state in which a part of the feeding device is exposed. In the mounted state, the floating positioning portion is the external sheath. By receiving the binding of the tube, the connection between the connecting ear and the positioning part of the feeding device is secured and the connecting ear is prevented from separating from the fixed head, and the external sheath tube completely secures the feeding device. When exposed, the feeding device is in the releasing state, and in the releasing state, the floating positioning part removes the acting force that maintains the bond between the connecting ear and the positioning part, so that the connecting ear of the feeding device is released. The transport device for an easy-to-control feeding device according to claim 1, wherein the transport device can be separated from the positioning unit. In the mounted state, the outer side of the floating positioning portion in the radial direction abuts on the inner wall of the outer sheath tube, the back side of the floating positioning portion in the radial direction abuts on the connecting ear portion, and the floating positioning portion and the feeding device are connected. The transport device for an easy-to-control feeding device according to claim 35, wherein all of the floating positioning portions are located outside the diameter direction of the feeding device at the contact portion of the selvage portion. The easy-to-control feeding device according to claim 35, wherein the floating positioning portion is equal to or higher than the outer wall of the fixed head in the radial direction in the mounted state. Transport equipment. The transport device for an easy-to-control feeding device according to claim 1, wherein the floating positioning unit and the positioning unit include an area in which at least a part thereof overlaps in the circumferential direction. The connecting selvage has a U-shaped or annular structure, one side of the opening of the U-shaped structure or one side of the annular structure is connected to the feeding device, and the positioning portion on the fixed head is a positioning protrusion, the U The transport device for an easy-to-control feeding device according to claim 1, wherein the mold structure or the annular structure is coupled to the positioning protrusion. The transport of the easy-to-control feeding device according to claim 3, wherein an insertion groove is formed on the outer periphery of the positioning protrusion, that is, the outer wall of the fixed head, and the connecting ear portion is superimposed in the insertion groove. apparatus. The floating positioning portion has a single strip type structure, or the floating positioning portion has a fork structure, the non-fork type structure of the floating positioning portion is fixed to the outside of the fixed head, and the far end of the fork structure is connected. The transport device for an easy-to-control feeding device according to claim 1, wherein the transport device extends to the outside of the connected selvage portion so as to overlap the ear portion. The transport device for an easy-to-control feeding device according to claim 1, wherein the portion to be connected to the connecting selvage portion of the floating positioning portion is stretched to the same thickness or non-same thickness. The control according to claim 1, wherein the coupling connection structure of the feeding device and the positioning portion is a connecting portion of the feeding device, and the connecting ear portion of the feeding device is at least a part of the connecting portion. Easy-to-use transport device.

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